Congenital Heart Disease in Children Clinical Trial
— DIETCHIRCARDOfficial title:
Controlled, Randomized, Double-blind, Monocentric Clinical Study Evaluating the Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation, After Surgery for Congenital Heart Disease, in Children Aged Zero to Two Years Old
Verified date | June 2020 |
Source | Queen Fabiola Children's University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.
After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The
caloric intake is not the only important nutritional variable in PICU. The protein intake
objective is around 1,5g/kg/d in order to reduce muscular catabolism.
The aim of this study is to compare the impact of an isocaloric enteral diet, either
fortified by milk concentration (in order to increase the protein intake) or by a supplement
of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart
disease.
Status | Terminated |
Enrollment | 41 |
Est. completion date | April 17, 2020 |
Est. primary completion date | April 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Years |
Eligibility |
Inclusion Criteria: - Children from 0 to 2 years undergoing cardiac surgery (corrective or palliative) for congenital heart surgery, with or without extracorporeal circulation - Expected stay of 5 days in PICU after surgery - Expected need of invasive ventilation for 48h after surgery - Expected need for enteral feeding during 5 days. - Obtaining the informed consent of the child's legal guardian after being informed of the goals, benefits and potential risks of this study Exclusion Criteria: - Medical indications for specific diet - ECMO - Dialysis |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Universitaire Des Enfants Reine Fabiola | Brussels |
Lead Sponsor | Collaborator |
---|---|
Queen Fabiola Children's University Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | positive nitrogen balance | Day 5 post operative | ||
Secondary | duration of enteral feeding | duration in hour | up to 120 days post operative | |
Secondary | duration of invasive or non-invasive ventilatory support | duration in hour | up to 120 days post operative | |
Secondary | length of hospital stay in intensive care unit | duration in hour | up to 120 days post operative | |
Secondary | length of hospital stay in hospital | duration in hour | up to 120 days post operative |
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